Fetal EchoScan
by Brightheart
510(k) K242342
Fetal EchoScan is a medical device (FDA Class II; FDA product code POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer) made by Brightheart, cleared under FDA 510(k) K242342 on 14 Nov 2024, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242342 | Date14 Nov 2024 | StatusActive |
Official records
- FDA 510(k) database K242342
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- POK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2060
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K242342
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| B-Right Screen Fetal Heart V1.0.0 | V1.0.0 | 03760415600000 | — | On the market |
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